FDA Registration
Active
🇺🇸 United States
INFAB, LLC.
Reg #: 2024351
·
FEI: 2024351
·
Expires 2026
Products
9
Proprietary Names
13
Establishment Types
4
Classifications
9
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Registration Details
- Registration Name
- INFAB, LLC.
- Registration Number
- 2024351
- FEI Number
- 2024351
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1040 Avenida Acaso
- City
- CAMARILLO
- State
- CA
- ZIP
- 93012
- Country
- US
Regulatory Submissions
- 510(k) Number
- K896289
Owner / Operator
- Firm Name
- INFAB, LLC
- Operator Number
- 2024351
- Address
- 1040 Avenida Acaso, --
- City
- Camarillo
- State
- CA
- Postal Code
- 93012
- Country
- US
- Correspondent
- Javier Rico
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screen, Leaded, Operator Radiation Protector | EAK | Class 1 | Radiology | No | 2024-05-17 |
| Apron, Leaded | EAJ | Class 1 | Radiology | No | 1998-05-20 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-05-07 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2025-08-18 |
| Apron, Protective | IWO | Class 1 | Radiology | No | 2019-04-25 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2024-01-31 |
| Radiographic Protective Glove | IWP | Class 1 | Radiology | No | 2009-06-23 |
| Shield, Eye, Radiological | IWS | Class 1 | Radiology | No | 2025-12-10 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2023-05-24 |
Proprietary Names
INFAB Mobile Radiation Protection Barriers and Shields
Smart Armor apron
Isolation Gown
UnderShield Supplemental Radiation Shielding Garment
Kerr Total Care
Patient Transfer Device
Lightning Aprons
Classic Aprons
Revolution Aprons
Revolution gloves
Leaded Eyewear
Radiation Protection Glasses
POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device